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Kangaroo 461355Recalls & reported problems

Cardinal Health 200, LLC · Radiopaque Line, Safe Enteral Connections · Class 2

Adverse event reports
8
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521067394), received between Jun 17, 2019 and Dec 14, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Detachment of Device or Device Component5
  • Disconnection2
  • Break1

Patient problems

  • No Consequences Or Impact To Patient4
  • No Known Impact Or Consequence To Patient2
  • Insufficient Information1
  • Urinary Retention1

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

    THE CUSTOMER REPORTED THAT THE HUB OF FEEDING TUBE FELL OFF WHILE IT WAS STILL PLACED IN THE PATIENT AND BEDSIDE NURSE QUICKLY REMOVED THE PRODUCT AND KEPT AS SAMPLE. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE WHOLE PURPLE PART WAS DISCONNECTED, AND THE DEVICE WAS REMOVED; HOWEVER, IT WAS UNKNOWN IF THE DEVICE WAS REPLACED. PER CUSTOMER, THE PATIENT HARM INFORMATION IS UNKNOWN AT THIS TIME.

    Patient problems: Insufficient Information

    MAUDE report 15983648 ↗
  • MalfunctionMar 26, 2020Break; Break

    THE CUSTOMER REPORTED THAT THEY OBSERVED A SMALL PINPOINT BREAK BENEATH THE HUB OF THE FEEDING TUBE. THE TUBE WAS REMOVED AND REPLACED WITH A NEW FEEDING TUBE. THIS OCCURRED IN THE NICU OF THE HOSPITAL. THERE WAS NO PATIENT HARM.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9886084 ↗
  • MalfunctionMar 13, 2020Disconnection; Disconnection

    THE CUSTOMER REPORTED THAT THE CAP SEPARATED FROM THE TUBING. THERE WAS NO PATIENT INJURY.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9829342 ↗
  • MalfunctionMar 11, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    THE CUSTOMER FROM NICU REPORTED THAT DURING USE, THE CAP OF THE DEVICE SEPARATED FROM THE TUBING.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9820903 ↗
  • MalfunctionNov 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    THE CUSTOMER REPORTED THAT THE INFANT HAD THE NASOGASTRIC TUBE IN PLACE. WHEN THE PLACEMENT WAS CHECKED, THE PURPLE CAP WAS NOTED TO BE MISSING. THE PURPLE COVER WAS FOUND ON THE FLOOR. THERE WAS NO HARM TO THE PATIENT.

    Patient problems: Urinary Retention

    MAUDE report 9375533 ↗
  • MalfunctionSep 20, 2019Disconnection; Disconnection

    THE CUSTOMER REPORTED THAT THE TUBING OF THE DEVICE WAS BROKEN FROM THE PURPLE ADAPTER.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9100890 ↗
  • MalfunctionJun 28, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    THE CUSTOMER STATES THAT THE NURSE INSERTED A NASAL GASTRIC FEEDING TUBE AND SECURED IT WITH TEGADERM TO THE PATIENT'S FACE. THE NEXT MORNING THE EXTENSION TUBING WAS STILL ATTACHED TO THE HUB, BUT THE HUB WAS NOT ATTACHED TO THE NG TUBING. THE NG TUBING REMAINED SECURED WITH TEGADERM TO PATIENT'S FACE. THE NG TUBING WAS REMOVED INTACT WITHOUT THE HUB. THE TUBE WAS REMOVED JUST AS IT NORMALLY WOULD BE AS IF THE HUB WAS STILL ATTACHED. ALL PIECES RECOVERED. THE PATIENT TOLERATED IT WELL.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8744606 ↗
  • MalfunctionJun 17, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    THE CUSTOMER REPORTS THE CONNECTOR DETACHED FROM THE FEEDING TUBE LEAVING PART OF THE TUBE OUTSIDE OF THE PATIENT. THE NURSE REMOVED THE TUBING WITH THEIR FINGERS THE SAME AS ANY OTHER FEEDING TUBE REMOVAL. NO MEDICAL INTERVENTION WAS REQUIRED. THE FEEDING TUBE WAS ORIGINALLY PLACED ON (B)(6) 2019.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8704748 ↗

Other TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices

All TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.